Transdermal drug delivery systems with polyisobutylene face adhesive

Abstract

Described are transdermal drug delivery systems for extended delivery of a therapeutic agent in the form of a flexible finite system for topical application, comprising (i) a polymer matrix comprising a therapeutic agent and (ii) a face adhesive layer disposed on a skin-contacting side of the polymer matrix comprising a rubber-based polymer. Methods of making and using such systems also are described.

What is claimed is: 
     
         1 . A transdermal drug delivery system for extended delivery of a therapeutic agent in the form of a flexible finite system for topical application, comprising (i) a polymer matrix comprising a therapeutic agent and (ii) a face adhesive layer disposed on a skin-contacting side of the polymer matrix comprising a rubber-based polymer. 
     
     
         2 . The transdermal drug delivery system of  claim 1 , wherein the rubber-based polymer of the face adhesive layer is selected from polyisobutylene polymers, styrene-isoprene-styrene polymers, and combinations thereof. 
     
     
         3 . The transdermal drug delivery system of  claim 1 , wherein the face adhesive layer comprises a rubber-based pressure-sensitive adhesive comprising the rubber-based polymer and, optionally, one or more tackifiers and/or plasticizers. 
     
     
         4 . The transdermal drug delivery system of  claim 3 , wherein the rubber-based pressure-sensitive adhesive comprises at least 90% by dry weight of the face adhesive layer. 
     
     
         5 . The transdermal drug delivery system of  claim 3 , wherein the rubber-based pressure-sensitive adhesive comprises at least 95% by dry weight of the face adhesive layer. 
     
     
         6 . The transdermal drug delivery system of  claim 3 , wherein the face adhesive layer further comprises one or more components selected from fillers, antioxidants and penetration enhancers. 
     
     
         7 . The transdermal drug delivery system of  claim 1 , wherein the face adhesive layer is free of acrylic polymers and is free of silicone polymers. 
     
     
         8 . The transdermal drug delivery system of  claim 1 , wherein the therapeutic agent comprises one or more functional groups and the face adhesive layer is free of counter ions to the one or more functional groups. 
     
     
         9 . The transdermal drug delivery system of  claim 1 , wherein the therapeutic agent comprises one or more functional groups and the transdermal drug delivery system is free of counter ions to the one or more functional groups. 
     
     
         10 . The transdermal drug delivery system of  claim 1 , formulated to achieve sustained delivery of the therapeutic agent over a period of time of at least 3 days, at least 4 days, or at least 7 days. 
     
     
         11 . The transdermal drug delivery system of  claim 1 , formulated to achieve a flux drop of less than 30% over an application period of at least 3 days, at least 4 days, or at least 7 days. 
     
     
         12 . The transdermal drug delivery system of  claim 1 , further comprising a backing layer. 
     
     
         13 . The transdermal drug delivery system of  claim 1 , further comprising a release liner. 
     
     
         14 . A method of transdermally delivering a therapeutic agent, comprising applying a transdermal drug delivery system according to  claim 1  to the skin or mucosa of a subject in need thereof. 
     
     
         15 . The method of  claim 14 , wherein the transdermal drug delivery system is applied for a duration of at least 3 days, at least 4 days, or at least 7 days. 
     
     
         16 . A method of preparing a transdermal drug delivery system for extended delivery of a therapeutic agent in the form of a flexible finite system for topical application, comprising applying a face adhesive layer comprising a rubber-based polymer on a skin-contacting side of a polymer matrix comprising the therapeutic agent.